Triaminic description, usages, side effects, indications, overdosage, supplying and lots more!

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Triaminic

Novartis Consumer Health, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Acetaminophen 160 mg

Chlorpheniramine maleate 1mg

Dextromethorphan HBr 7.5mg

Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Triaminic Uses

  • temporarily relieves
    • minor aches and pains
    • headache
    • minor sore throat pain
    • sneezing
    • itchy nose or throat
    • itchy, watery eyes due to hay fever
    • cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 4 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

Do Not Use

  • in a child under 4 years of age
  • if your child is allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
    • for the purpose of making your child sleepy

Ask a doctor before use if your child has

  • liver disease
  • glaucoma
  • a breathing problem such as chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts, such as occurs with asthma

Ask a doctor or pharmacist before use if your child is taking

  • sedatives or tranquilizers
  • the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • this product does not contain directions or warnings for adult use
  • do not give more than directed
  • may be given every 6 hours. Do not give more than 4 doses in 24 hours unless directed by a doctor.

Age

Dose

children under 4 years of age

do not use

children 4 to under 6 years of age

do not use unless directed by a doctor

children 6 to under 12 years of age

2 teaspoonfuls (10 mL)

Triaminic Other information

  • each teaspoonful contains: sodium 6 mg
  • contains no aspirin
  • store at controlled room temperature 20-25C (68-77F)

Inactive ingredients

benzoic acid, citric acid, dibasic sodium phosphate, edetate disodium, FD&C red #40, flavors, glycerin, polyethylene glycol, purified water, sorbitol, sucrose

Questions or comments?

call 1-800-452-0051

Additional Information Listed on Other Panels

Children’s Triaminic Syrup

Multi-Symptom Fever

Acetaminophen (Pain Reliever/Fever Reducer)

Chlorpheniramine maleate (Antihistamine)

Dextromethorphan HBr (Cough Suppressant)

  • Fever
  • Cough Relief up to 8 Hours
  • Runny Nose
  • Sore Throat
  • Aches & Pains

PARENTS: Learn about teen medicine abuse. www.StopMedicineAbuse.org

Child-Resistant Safety Cap

TAMPER-EVIDENT FEATURE: DO NOT USE IF SAFETY SEAL PRINTED WITH “TRIAMINIC” AROUND BOTTLE CAP IS BROKEN OR MISSING

Distr. by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©20XX

Principal Display

Triaminic

Acetaminophen, Chlorpheniramine maleate, Dextromethorphan SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-6394
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 160 mg
Chlorpheniramine Maleate CHLORPHENIRAMINE 1 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 7.5 mg

Inactive Ingredients

Ingredient Name Strength
BENZOIC ACID
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC
EDETATE DISODIUM
FD&C RED NO. 40
GLYCERIN
POLYETHYLENE GLYCOL 1450
sorbitol
SUCROSE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 100 in 1 BOTTLE
3 NDC:0067-6394-34 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-09-27


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Be sure to consult your doctor before taking any medication!
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